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Public Involvement in Significant Risk Reduction Decisions on Registered Pesticides

Public Involvement in Significant Risk Reduction Decisions on Registered Pesticides

[OPP-34058; FRL-4864-7]

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: This notice describes the Agency`s general policy to provide opportunities for public involvement before reaching final significant risk reduction decisions on registered pesticides. Through this notice, the Agency is soliciting comments and suggestions from interested parties concerning the mechanisms used for public involvement prior to the Agency reaching such decisions, particularly those reached through the Special Review process and negotiated settlement agreements.

DATES: Written comments, identified by the document control number ``OPP-50787,`` must be received on or before October 11, 1994.

ADDRESSES: Comments should be submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Hand delivered items should be delivered to: Public Response and Program Resources Branch, Field Operations Division, Office of Pesticide Programs, Environmental Protection Agency, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Office hours are from 8 a.m. to 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph E. Bailey, Special Review and Reregistration Division (7508W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Special Review Branch, Crystal Station #1, 3rd Floor, Room WF32G, 2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8173.


  1. Introduction

    Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is given the responsibility of regulating the manufacture, sale, and use of pesticides to ensure that there are no unreasonable adverse effects to human health or the environment as a result of the use of a pesticide. Regulatory decisions that carry out this responsibility are reached by evaluating the risks and benefits associated with the pesticide`s use, as well as with alternative pesticides and pest control methods. This process determines what degree of risk is reasonable while taking into consideration the economic and social benefits gained from the pesticide, ensuring that the risks do not outweigh the benefits. The Agency has several mechanisms in place to effect this balance if the results of the risk and benefit evaluations indicate that unreasonable adverse effects are likely from the pesticide`s use and that regulatory action is warranted. Each of these mechanisms has advantages and disadvantages that range from the length of time required to reach the regulatory decision, the amount of Agency resources necessary, to the degree the public is involved.

  2. Background

    When the Agency has reason to believe that the use of a currently registered pesticide may result in unreasonable adverse effects to human health or the environment, a structured review of the pesticide of concern may be carried out through the formal Special Review process. The risk criteria initiating this review process and the regulations governing it are set forth in 40 CFR part 154. The formal Special Review process as set forth in these regulations provides the opportunity for public input through the solicitation of comments at two distinct stages of the review: The formal announcement of initiation of the Special Review (Position Document 1) and the announcement of the Agency`s preliminary decision (Position Document 2/3). The Agency considers all significant comments before reaching a final decision.

    The formal Special Review process can prove to be resource intensive and time-consuming due in part to its discrete stages and the opportunities provided for public comment. The Government Accounting Office (GAO) issued reports in 1980 and 1986 concluding that the Office of Pesticide Programs (OPP) was not completing reviews of potentially hazardous pesticides in a timely manner. Similarly, in 1984, the House of Representatives Committee on Government Operations found that the Special Review process was not quickly reaching decisions on potential risks that were found to be associated with certain pesticide uses. Recently, the Agency`s Office of Inspector General (OIG) conducted an audit of the Special Review process and presented its results in a final report dated July 22, 1993. This report, while critical of some aspects of the Special Review process and the time involved in completing the reviews, also raised concerns about using negotiated settlement agreements to achieve pesticide risk reduction rather than initiating new Special Reviews. The OIG concluded that negotiated settlement agreements do achieve risk reduction more quickly than the formal Special Review process, but was concerned that negotiated decisions were made between the Agency and pesticide registrants at the expense of public involvement.

    The report also reflected concern that the Agency does not notify the public of risk concerns while a decision is being made whether or not to formally initiate a Special Review; i.e., during the pre-Special Review (that period of time after a preliminary (Grassley-Allen) notification is sent to the registrants but before issuance of the public announcement (Position Document 1) initiating the Special Review).

    Other mechanisms are available to achieve pesticide risk reduction at a more accelerated pace than is afforded through a normal Special Review. They include the issuance of a Position Document 1/2/3 which combines the first two position documents issued in the formal Special Review process into one. This is used when enough information is available at the outset of a Special Review to fully assess the risks and benefits and reach a proposed decision. Additional mechanisms include issuing Notices of Intent to Cancel (NOIC), Suspension Orders, or Emergency Suspension Orders as provided under FIFRA section 6. These mechanisms can be used to remove pesticides from the market that pose significant risks or imminent hazards.

    Although the Agency has used all of these different means in the past to effect pesticide risk reduction, recently, negotiated settlement agreements have been used more and more frequently. Through the process of negotiation, the Agency and the registrant(s) reach a mutual agreement that legally commits the registrant(s) to specific measures that will reduce potential risks associated with a pesticide`s use. Such measures typically include modifying the terms of registration by cancellation of uses, changing use patterns, changing application methods, or altering the manufacturing formula. The same scientific principles and weight- of-evidence information that govern the decisions made during a formal Special Review also apply to negotiated settlements; that is, carefully analyzing risks, benefits, and alternative pest control methods to ensure that the risk reduction measures desired will not result in risks that outweigh the benefits or that risks are reduced to the greatest extent practical while data are being generated to better understand the risks associated with the use of the pesticide. The agreements also make every effort to ensure that a pesticide use will not shift to an alternative pesticide or pest control method of equal or greater risk concern or result in the trading of one risk for another. By using the same analyses as those used in a formal Special Review, the public and the environment should be afforded the same level of protection in a more timely fashion. The main difference is that the Special Review process formally provides opportunities for public involvement before reaching risk reduction decisions.

    In all negotiated settlement agreements, the Agency reserves the right to take additional regulatory action if evidence arises that warrants it. Similarly, the Agency can remove restrictions if additional data are reviewed later that indicate risks are of less concern than previously thought. Negotiated settlement agreements, however, should not be viewed as an exclusive mechanism to achieve a final risk reduction decision. They may be used to reach an ultimate goal of the Agency such as use cancellation or use reduction, or they may be used as an interim measure to reduce risks while additional data are being generated, or during any stage of an ongoing Special Review prior to the Agency making its final decision. Although the Agency has been criticized for neglecting to include affected constituency groups (e.g., users and public interest groups) in risk reduction decisions made through negotiated settlement agreements and for not making the general public aware of risk concerns for pesticides being considered for the formal Special Review process, several steps already have been taken to open up the decision-making process to the public whenever possible. Specific examples of how the Agency has provided for public involvement in recent negotiated settlement agreements are provided below.

    1. Parathion. In September 1991, due to concerns of acute poisonings to workers exposed to parathion, the Agency reached a negotiated settlement agreement with the registrants whereby all but nine uses of parathion were voluntarily canceled. The Agency held public hearings in December 1992 to solicit public involvement and gain additional information on the risks and benefits of the remaining nine uses. These hearings were held in Amarillo, Texas; Lincoln, Nebraska; and Baltimore, Maryland and were announced in the Federal Register to encourage all interested parties to participate. The Agency also polled State and regional offices for advice and input.

    2. 2,4-D. In June 1992, in an effort to reduce the amount of exposure to persons applying 2,4-D and therefore reduce potential risks, the Agency met with the 2,4-D Task Force and requested that they include end-user input in the development of such measures. Also, through meetings and telephone conversations, the Agency actively included distributors and end-users to help develop effective and fair exposure reduction measures.

    3. Granular carbofuran. According to 40 CFR 154.35(c), the Agency must publish a notice in the Federal Register to modify an earlier determination in a way that might increase a risk that was the subject of a Special Review. During the final stages of the Special Review of granular carbofuran, the Agency negotiated a settlement agreement with the registrants to phase out most uses. In order to extend the registration for the use of carbofuran on rice, the Agency formally requested public comment as required under 40 CFR 154.35(c). The denial of extensions of registrations for two other uses, corn and sorghum, did not require such request for comment. The Agency, however, announced in the Federal Register its decision to deny extension of the registration for corn and sorghum uses and allowed the opportunity for comment from affected individuals or groups.

    4. Azinphos-methyl. Due to its concerns regarding the hazards azinphos-methyl posed to fish from use on sugarcane in Louisiana, the Agency reached an agreement with the registrants to amend their registrations in April 1993. The agreement, including prescription use, was the result of a cooperative effort between the Agency, Louisiana State officials, and the pesticide registrants. Through the use of public workshops held in Louisiana to collect additional information about azinphos-methyl use and alternative pesticides, the Agency advanced the use of negotiated settlement agreements by actively soliciting public input that contributed to the decision-making process. The workshops were announced in the Federal Register and participation of all interested parties was encouraged.

    Furthermore, in order to keep the public better informed of its risk concerns, the Agency has, as a matter of general policy, made available to the public those dockets established for pre-Special Review chemicals which have had private notifications issued for 6 months but have not yet had a Special Review formally initiated. The Agency will continue this procedure. In addition, the Agency will announce those Special Review and pre-Special Review chemicals for which a public docket is available in the January edition of the quarterly Pesticide Reregistration Progress Report. Also, OPP`s ``Status of Pesticides in Reregistration and Special Review`` (Rainbow Report) provides a comprehensive status of all chemicals currently undergoing reregistration and Special Review. To receive copies of these reports or to be added to the mailing list, please write or fax the following address: U.S. EPA, NCEPI, P.O. Box 42419, Cincinnati, OH 45242- 0419, Telephone (513) 891-6561, Fax (513) 891-6685.

    Mechanisms that may provide opportunities for public input that the Agency has not frequently used but will consider in the future, include the following:

    • Holding public hearings provided under FIFRA section 6(b)(2). This section of FIFRA allows the Agency to issue a notice to hold hearings to determine whether or not a registration should be canceled or its classification changed and ``such notice shall be sent to the registrant and made public.``

    • Requesting additional information and views from interested parties, particularly users, user associations and public interest groups, through solicitation of comments and notification of public hearings provided under FIFRA section 21(b).

    • Publishing the Agency`s risk concern and proposed regulatory action for a particular pesticide in the Federal Register, soliciting public comment. In fact, the Administrative Conference of the United States recently adopted Recommendation 93-5 concerning Procedures for Regulation of Pesticides. One of its final recommendations was that EPA provide public notification of pesticide risk concerns once negotiations begin, publicize the availability of a public docket, the proposed settlement and establish a ``compliance docket`` to address the effectiveness of the mitigated measures formally adopted. This recommendation was published in the Federal Register of February 1, 1994 (59 FR 4675).

    The Agency is committed to the responsibilities set forth in FIFRA and views pesticide risk reduction as an evolving process where flexibility is a key element for successfully reducing risk posed by pestere negotiated settlement agreements are appropriate, it will be the Agency`s general policy to provide opportunity for public involvement, whenever possible. The Agency understands the importance of public input in reaching regulatory decisions, especially input from grower and user groups closely associated with a particular pesticide of concern who may provide useful risk and benefit information that the Agency would find helpful in reducing risks while not significantly reducing the efficacy of the pesticide. Other critical information that could be obtained through public input and that the Agency views as essential to making effective decisions includes human or environmental incident data held by end-user groups or other environmental organizations. The Agency will continue to consider those mechanisms used in the past to encourage public involvement and will maintain an openness for innovative approaches that will allow for greater public involvement in negotiated settlement agreements.


    The Agency is requesting comments and suggestions on its existing or proposed means to acquire public input that can be used to enhance our risk/benefit analyses and the resulting regulatory decisions. The Agency is also seeking comment on the advantages and disadvantages of having affected or interested parties involved in negotiations.

Dated: July 29, 1994.

Lynn R. Goldman, Assistant Administrator for Prevention, Pesticides and Toxic Substances.

[FR Doc. 94-19293 Filed 8-9-94; 8:45 am]